Feasibility Study: Evaluation of the Ulthera® System for Treatment of Abdominal Tissue
Enrolled subjects will receive one UltherapyTM treatment on the abdomen. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Feasibility Study: Evaluation of the Ulthera® System for Efficacious and Safe Treatment of Laxity/Crepiness and Texture of Abdominal Tissue|
- Improvement laxity/crepiness and texture of abdominal tissue [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]Determined by a masked, qualitative assessment of photographs at 90 days post treatment compared to baseline
- Overall aesthetic improvement [ Time Frame: 180 days post-treatment ] [ Designated as safety issue: No ]The Global Aesthetic Improvement Scale scores will be obtained from the investigator and subject, comparing post-treatment photos to pre-treatment photos.
|Study Start Date:||March 2012|
|Study Completion Date:||April 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Experimental: Study treatment
All enrolled subjects will receive one Ulthera System Treatment.
Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ultherapy™
This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System for improving laxity/crepiness and texture of abdominal tissue. Changes from baseline in the laxity, crepiness and texture of abdominal skin will be assessed at each study follow-up visit. Global Aesthetic Improvement Scale scores, assessments of dermal thickness, and patient satisfaction questionnaires will also be obtained.